Catheters are used for many medical procedures, including inserting a guide wire, delivering a stent, and delivering and inflating a balloon.
Catheterization procedures are very commonly performed for diagnosis and treatment of diseases of the heart and vascular system. The catheterization procedure is generally initiated by inserting a guide wire into a blood vessel in the patient's body. The guide wire is then guided to the desired location, most commonly in one of the heart vessels or elsewhere in the vascular system. At this point the catheter is slid over the guide wire into the blood vessel and/or heart. Once the catheter is in the desired position, the guide wire can then be removed, leaving the catheter in location. Alternatively, in some procedures, the catheter is inserted without using a guide wire. The catheter may be used to pass ancillary devices into the body, such as an angioplasty balloon, or to perform other diagnostic or therapeutic procedures.
In order to facilitate the guide wire insertion and the subsequent catheter application, the physician generally performs the procedure with the assistance of a fluoroscope, as is well known in the art. The fluoroscope produces a real-time image showing the continued progress of the guide wire, or the catheter, through the patient's body.
The fluoroscope generates a high level of X-ray radiation, which poses a significant danger to medical personnel exposed thereto, as is well known in the art. In order to provide protection from radiation exposure, the attending medical personnel generally wear a heavy, cumbersome protective lead garment which covers the entire body and neck, or use various lead shields including transparent glass face and eye shields.
It is desirable to know the precise linear and rotational state of the catheter. Japanese patent no. 2000-010467 (2000) by Tokai Rika Co Ltd. et al, “CATHETER OPERATION SIMULATOR AND SIMULATION METHOD USING THE SAME” mentions a catheter operation simulator characterized by having an insertion/rotation detection sensor which outputs detected insertion/rotation data, providing the amount of insertion and rotation of a catheter tube. However the Tokai Rika patent is focused on simulation and provides only position feedback—not active means for controlling position.
One way to improve control of the catheter is to provide a control system that moves the catheter via motors. One such system is described in PCT publication no. WO/99/45994 (1999), by Dalia Beyar “REMOTE CONTROL CATHETERIZATION”, which describes a remote control catheterization system including a propelling device, which controllably inserts a flexible, elongate probe into the body of a patient. A control console, in communication with the propelling device, includes user controls which are operated by a user of the system remote from the patient to control insertion of the probe into the body by the propelling device.
It is an object of some aspects of the WO/99145994 invention to provide apparatus and methods of catheterization that allow medical personnel to be distanced from the vicinity of the fluoroscope and its resultant radiation, thereby reducing radiation exposure of the personnel. It is a further object of some aspects of the WO/99145994 invention to provide a mechanism for remote control performance of catheterization procedures.
The present invention is intended to provide an intuitive user interface to a remote control catheterization system, such as WO99/45994. The present invention is based on a handle element that provides the user with an experience that closely resembles actual insertion and rotation of a catheter or guide wire. More specifically, the present invention enables the user to move the handle along a longitudinal axis and around that axis, thereby emulating the primary types of motion associated with insertion of a catheter or guide wire (herein “catheter” applies equally for a catheter or a guide wire).
In a preferred embodiment of the present invention, the user's movement of the handle is translated by the system to movement of the catheter.
In a preferred embodiment of the present invention, feedback from the catheter is converted by the invention to tactile forces acting on the handle.
In a preferred embodiment of the present invention, the translation (handle to catheter) ratio and the tactile feedback (catheter to handle) ratio are user-controlled.
In a preferred embodiment of the present invention, indicators and controls, are included on the base of the handle or in proximity.
In a preferred embodiment of the present invention, a safety mechanism is provided to ensure that the handle does not move the catheter accidentally.
In summary, it is a main object of the present invention to provide a user interface for remote control catheterization with the following several objects and advantages:                easy to grasp        provides operator with safe, intuitive, precise control of linear and rotational movement of the catheter        provides the operator with tactile feedback regarding forces acting on the catheter        provides operator with means for varying the scaling of the control signals sent and feedback received        provides operator with easy access to controls for catheter operations, such as injecting a contrasting agent or inflating a balloon.        
Still further objects and advantages will become apparent from a consideration of the ensuing description and drawings.